Inhalation device

ABSTRACT

An inhalation device is described for use with a medicament pack in which at least one container for medicament in powder form is defined between two sheets peelably secured to one another. The device comprises means for peeling the sheets apart at an opening station to open the container; and an outlet, communicating with the opened container, through which a user can inhale medicament in powder form from the opened container.

This application is a continuation if application Ser. No. 09/456,201filed Dec. 7, 1999 now U.S. Pat. No. 6,378,519, which was a continuationof application Ser. No. 09/1 66,557, filed Oct. 5, 1998 now U.S. Pat.No. 6,032,666 which is a continuation of Ser. No. 08/979,217, filed Nov.26, 1997, now U.S. Pat. No. 5,860,419, issued Jan. 19, 1999; which is adivisional of Ser. No. 08/467,469, filed Jun. 6, 1995, now U.S. Pat. No.5,873,360 issued Feb. 23, 1999; which is continuation of Ser. No.08/552,166, filed Nov. 2, 19957 now U.S. Pat. No. 5,590,645 issued Mar.1, 1991; which is a continuation of Ser. No. 08/175,174, filed Dec. 28,1993, now abandoned; which is a continuation of Ser. No. 07/663,145,filed Mar. 1, 1991, now abandoned.

FIELD OF THE INVENTION

This invention relates to an inhalation device by means of which a usercan inhale medicament in the form of a powder.

BACKGROUND OF THE INVENTION

Inhalation devices are known for use with blister packs in which themedicament is held in powder form in the blisters thereof. Such devicesinclude a puncturing member which punctures each blister in turn, thusenabling the medicament to be inhaled therefrom. It is an object of thepresent invention to provide an inhalation device the design of whichhas the potential, if desired, to handle a medicament pack having alarge number of discrete unit doses, without the device becomingunacceptably large.

According to the present invention there is provided an inhalationdevice for use with a medicament pack in which at least one containerfor medicament in powder form is defined between two members peelablysecured to one another, the device comprising means defining an openingstation for the said at least one container; means for peeling themembers apart at the opening station to open the container; and anoutlet, communicating with the opened container, through which a usercan inhale medicament in powder form from the opened container.

Preferably the medicament pack is formed from two elongate sheets whichdefine a plurality of medicament containers spaced along the lengththereof, means being provided for indexing each container in turn to theopening station.

The invention also provides a medicament pack for use in an inhalationdevice, the pack comprising an elongate strip formed from a base sheethaving a plurality of recesses spaced along its length and a lid sheethermetically but peelably sealed thereto to define a plurality ofcontainers, each container having therein inhalable medicament in powderform. The strip is preferably sufficiently flexible to be wound into aroll.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a rear view of a first embodiment of the invention;

FIG. 2 is an axonometric exploded view of the components of theembodiment of FIG. 1;

FIGS. 3a, 3 b and 3 c are an axonometric view, a longitudinal sectionand an end view (partly broken away) showing a clutch used in theembodiment of FIGS. 1 and 2;

FIGS. 4a and 4 b are an axial section and cross-section respectively, ona larger scale than FIGS. 1 and 2 of a mouthpiece which may be used inthe first embodiment (or in some other embodiment);

FIG. 5 is a front view of a second embodiment, with a cover thereofremoved to show the interior;

FIG. 6 is a rear view of the second embodiment, but showing the interiorthereof;

FIG. 7 is an axonometric front view of the second embodiment;

FIG. 8 is an axonometric rear view of the second embodiment;

FIG. 9 is an axonometric exploded view of the second embodiment;

FIG. 10 is a front view of a third embodiment, showing the interiorstructure thereof;

FIG. 11 is an axial view, on a larger scale, showing the mouthpiece ofthe third embodiment;

FIG. 12 is a view from below of the third embodiment;

FIGS. 13 to 16 show a fourth embodiment of the invention, FIG. 13 beingan underplan view, FIG. 14 a section on line A—A in FIG. 13, FIG. 15 asection on line B—B in FIG. 13, and FIG. 16 an exploded view on asmaller scale;

FIGS. 16a to 16 d show the fourth embodiment in successive stages ofoperation, and FIG. 16e is a section taken on line A—A in FIG. 16a;

FIGS. 17 to 20 show a fifth embodiment of the invention, FIG. 17 beingan end view, FIG. 18a section on line A—A in FIG. 17, FIG. 19a sectionon line B—B in FIG. 17, and FIG. 20 an exploded view;

FIGS. 21 to 24 show a sixth embodiment of the invention, FIG. 21 beingan end view, FIG. 22a section on line A—A in FIG. 21, FIG. 23a sectionon line B—B in FIG. 21, and FIG. 24 an exploded view;

FIGS. 25 to 29 show a modified clutch which may be used in thoseembodiments of the invention which require it, and are, respectively, afront view, a top view, a back view, a left side view and an axonometricview;

FIG. 30 is an exploded perspective view showing a further embodiment ofclutch which may be used;

FIG. 31 is an exploded perspective view of yet another embodiment ofclutch which may be used;

FIG. 31a is transverse section through the clutch shown in FIG. 31;

FIGS. 32 to 34 show successive positions of operation of anotherembodiment of the invention, in rear view; and

FIG. 35 is a perspective view on a larger scale showing an embodiment ofmedicament pack according to the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIGS. 1, 2 and 3 a to 3 c, these show an inhalationdevice in which is mounted a flexible strip 1 defining a plurality ofpockets 2 each of which contains a dose of medicament which can beinhaled, in the form of a powder. The strip 1 comprises a base sheet 3in which blisters are formed to define the pockets 2, and a lid sheet 4which is hermetically sealed to the base sheet 3 except in the region ofthe blisters, such a manner that the lid sheet and the base sheet can bepeeled apart. The sheets are sealed to one another over their wholewidth except for leading end portions thereof where they are preferablynot sealed to one another at all. The lid and base sheets are eachpreferably formed of a plastics/aluminum. laminate, and the lid and basesheets are preferably adhered to one another by heat sealing. By way ofexample, the lid material may be a laminate consisting of 50 gsm bleachkraftpaper/12 micron polyester (PETP) film/20 micron soft temperaluminum foil/9 gsm vinylic peelable heat seal lacquer (sealable toPVC), and the base material may be a laminate consisting of 100 micronPVC/45 micron soft temper aluminum foil/25 micron orientated polyamide.The lacquer of the lid material is sealed to the PVC layer of the basematerial to provide the peelable seal between the lid and base sheets.

The strip 1 is shown as having elongate pockets which run transverselywith respect to the length of the strip. This is convenient in that itenables a large number of pockets to be provided in a given striplength. The strip may, for example, be provided with sixty or onehundred pockets, but it will be understood that the strip may have anysuitable number of pockets.

The inhalation device comprises a body 10 defining three storagechambers, namely a chamber 11 in which the strip 1 is initially housedand from which it is dispensed, a chamber 12 for receiving the usedportion of the base sheet 3, and a chamber 13 within which the usedportion of the lid sheet can be wound up on a wheel 14. The chambers 11and 12 contain respective curved leaf springs 28 and 29, the purpose ofwhich is described below. The body defines a further chamber 15 whichhouses an index wheel 16. This has a plurality of grooves 17 extendingparallel to the axis of the wheel 16. The grooves are spaced at a pitchwhich is equal to the distance between the center lines of adjacentpockets 2. The chambers 11, 12, 13 and 15 are closed by a lid 30. Thechamber 15 communicates with the chambers 11, 12 and 13 via passages 31,33 and 32 respectively.

The chamber 15 communicates via a slit 18 which, in turn, extendsupwardly within a mouthpiece 20. The slot 18 also communicates with airinlets, as will be described below with reference to the specificmouthpiece shown in FIGS. 4a and 4 b. The mouthpiece 20 is provided withadditional air inlets 21 shown here in the form of a pair of circularapertures, though they may be of some other shape, as they are in FIGS.4a and 4 b. The primary purpose of the additional air inlets 21 is toprovide additional air to the user and thus reduce the resistance toinhalation, though they may serve one or more additional purposes, asthey do in FIG. 4a, and 4 b and as is described below. with reference tothose Figures.

A means is provided by which the user can rotate the index wheel and thelid wheel in steps of a predetermined size. This means comprises aratchet wheel 22 and a gear wheel 23, both connected to rotate in unisonwith the index wheel 16, a lever 24 arranged to rotate about the sameaxis as the ratchet wheel 22 and gear wheel 23, but independentlythereof, and a gear wheel 25 which meshes with the gear wheel 23 and isarranged to rotate the lid wheel 14. The lever 24 carries a pusher arm26, the end of which is arranged to engage the teeth of the ratchetwheel 22. The teeth of the ratchet wheel are also engaged by a pawl 27fixedly secured to the body 10. For reasons which will become apparentfrom the description below of the operation of this embodiment, the gearwheel 25 is not connected directly to the lid wheel 14, but is connectedvia a slipping clutch 50 which is housed within the lid wheel 14. Theeffect of the provision of this clutch is that slipping occurs betweenthe lid wheel and the gear wheel 25 when the force required to rotatethe lid wheel exceeds a predetermined amount.

The clutch 50 comprises a disc 51 provided with radially extendingserrations 52, or other surface roughness, which is held in engagementwith a similarly serrated or roughened surface 53 provided on an endface of the lid wheel 14 by a compression spring 54. The spring 54 bearsat one end against an inwardly directed surface 55 of the lid wheel andat the other end against a nut 56 threaded on a bolt 57.

The device described above can be made so as to be reusable after thedoses of medicament contained in the pockets 2 have all been dispensed.In that case, provision can be made for the user to gain access to theinterior of the device, for example by removing the lid 30, so as toinsert therein a fresh strip 1, for example in a cassette.Alternatively, however, the device may be made to be disposable once thestrip 1 with which it is supplied has been used up.

In either event, when the device is first used the bulk of the strip 1is within the chamber 11, kept in a relatively tight reel by the leafspring 28, with a short portion at the leading end thereof passing outof the chamber 11 through the passage 31 to the index wheel 16. Theforemost part of the leading end of the strip is peeled apart so thatthe leading end of the lid sheet 4 can be secured to the lid wheel 14,and so that the leading end of the base sheet 3 can enter the passage33. The end of the lid sheet 4 is held in place on the lid wheel 14 bymeans of a key 34 which is a force fit in a slot 35 in the wheel 14.

A user desiring to use the device pushes the lever 24 in ananticlockwise direction, as viewed in FIG. 1, so that the pusher arm 26urges the ratchet wheel 22 through an angle equal to the angulardistance between two adjacent teeth. This causes the ratchet wheel 16 torotate by an angular amount equal to the pitch of the groove 17 thereofand thus equal to the distance between two adjacent pockets 2 in thestrip 1. This brings a pocket 2 opposite the slot is in the body 10.Since the ratchet wheel 22 and gear wheel 23 move in unison, and sincethe gear wheel 25 meshes with the gear wheel 23, movement of the lever24 also causes the lid wheel 14 to rotate. This peels a sufficientportion of the lid sheet 4 away from the base sheet 3 to expose thecontents of the pocket 2 which is being brought into alignment with theslot 18.

When the user inhales through the mouthpiece 20 the flow of air whichthis produces entrains powderer from the opened pocket, so that thepowder is inhaled by the user one way in which this can occur isexplained in more detail below with reference to the embodiment ofmouthpiece shown in FIGS. 4a and 4 b. Each time the above procedure isrepeated a further length of lid sheet is wrapped around the lid wheel14 and a further length of base sheet enters chamber 12 through passage33. The leaf spring 29 therein ensures that the base sheet is coiled upand does not snag on the wall of the chamber 12.

One effect of winding up the lid sheet on the lid wheel 14 is that theexternal diameter of the wheel plus the sheet wound thereon graduallyincreases. Were it not for the use of a slipping clutch to connect thegear wheel 25 to the lid wheel 14 this would have the result thatsuccessive operations of the lever 24 would try to cause a progressivelylonger length of lid sheet to be wound onto the lid wheel. The slippingclutch 50, however, avoids this effect, the clutch slipping each time byan amount sufficient to ensure that for every operation of the lever theamount of lid sheet wound on is precisely equal to the pitch of thepockets 2.

FIGS. 4a and 4 b show a portion of the index wheel 16 with a pocket 2therein, in conjunction with a mouthpiece which differs slightly fromthe mouthpiece 20 shown In FIGS. 1 to 3, and which is denoted byreference numeral 120. The mouthpiece 120 has air inlets 140, to whichreference in general terms has already been made in connection withFIGS. 1 to 3, and a central powder outlet 119, one end of which is opento the pocket 2 and the other end of which opens into the interior ofthe mouthpiece 120.

When a user inhales through the mouthpiece 120 this causes air to flowin through the inlets 140 and thence through the pocket 2,” into thepowder outlet 119, and out through the mouthpiece 120. By thus directingthe flow of air through the pocket 2, efficient entrainment of powder inthe airflow is achieved, with consequent efficient emptying of thepocket. The mouthpiece 120 is provided with additional air inlets 121,shown here by way of example as being four in number, which opentangentially into the mouthpiece. When the user inhales air is drawninto the mouthpiece not only through the air inlets 140 but also throughthe air inlets 121, and the air entering through the inlets 121 producesa swirling airflow which helps to distribute powder effectively withinthe airflow and reduce the extent to which powder is deposited on theinside of the mouthpiece. This also helps to break up any aggregates ofpowder which may be present in the blister.

An alternative clutch arrangement is shown in FIGS. 25 to 29. In this,the index wheel 16 and the lid wheel 14 have respective toothed gearwheels 63 and 64 secured to them for rotation therewith. The directionof rotation is indicated by arrows in FIG. 27.

Gear wheel 63 has a toothed surface 65, with the teeth being providedcontinuously all the way round the surface 65 and at a constant pitch.By contrast, the gear wheel 64 has a toothed surface 66 from which someteeth are missing by virtue of the provision of radially extending slots67. The circumferential width of each slot at the surface 66 is equal toone tooth pitch. The drawings show three such slots, but it should beunderstood that there could instead be one slot, two slots, or more thanthree slots. To one side of each of the slots 67, in fact upstream ofeach slot as considered in the direction of rotation of the gear wheel64, a toothed section 68 is defined between the slot 67, and a narrowslit 69. The radially inner end of each slit 69 communicates with anaperture 70, so that each toothed portion 68 is connected to theremainder of the gear wheel 64 only by an arm 71. The gear wheel 64, orat least those portions thereof which provide the arms 71, is made of amaterial which permits the toothed portions 68 to flex resiliently backand forth in a circumferential direction. The rest position of theportions 68 is as shown in the drawings, but when a force is applied toa portion 68 in the direction of rotation of the gear wheel 64, theportion 68 can move so as to close the gap 67 at the radially outer end.This has the effect that a tooth is then “missing” not at the end of theslot 67 but at the end of the slit 69. When the circumferential forceapplied by the gear wheel 63 to the gear wheel 64 is below apredetermined level the toothed portions 68 remain in their restpositions and the gear wheel 64 behaves just as if it had a continuoustoothed surface like that of gear wheel 63. However, if the load exceedsa predetermined value, each time a toothed section 68 meshes with thegear wheel 63 it is moved circumferentially to close up the slot 67 atits outer end and open the slit 69. This movement of the toothed section68 by a distance equal to the tooth pitch has the effect of producingslippage of the gear wheel 64 with respect to the gear wheel 69 equal toone tooth pitch. In this way, the illustrated arrangement is able topermit a total slippage of the gear wheels with respect to one anotherby a maximum of a distance equal to three times the tooth pitch perrevolution, and hence a corresponding slippage of the lid wheel andindex wheel with respect to one another. As will be appreciated,providing more or fewer toothed sections than the three illustrated willpermit more or less than this maximum slippage.

A second embodiment of the inhalation device according to the inventionis shown in FIGS. 5 to 9. This is intended for use with a strip 201,similar to the strip 1 used in the first embodiment except as regardsthe spacing of the pockets (for which see below). In many respects thesecond embodiment resembles the first embodiment, and components in thesecond embodiment which correspond in general terms to particularcomponents in the first embodiment are denoted by the same referencenumerals, but with the addition of 200. The main difference between thefirst embodiment and the second embodiment is that in the latter thereis no index wheel corresponding to the index wheel 16 of the firstembodiment. Instead, indexing of the strip 1, to ensure that eachoperation of the lever advances the strip by an amount equal to thepitch of the pockets, is achieved by a resiliently flexible arm 250terminating in a tooth 252 which engages between adjacent pockets. Eachtime the lever 224 is operated the arm 250 is resiliently depressed as apocket slides past the tooth 252 thereof, and the tooth then springsback into engagement with the strip to the rear of the pocket which hasjust passed it.

It will be appreciated that, as in the case of the first embodiment, thediameter of the lid wheel 214 with the lid sheet thereon graduallyincreases during operation. Since a slipping clutch cannot be used inthis embodiment the effect just described is compensated by having thespacing of the pockets 2 gradually increasing towards the rear end ofthe strip.

One other difference which will be noted between the first and secondembodiments, is that in the latter the chambers 211 and 212 form asingle composite chamber, unlike the separate chambers 11 and 12 in thefirst embodiment. However, this need not be so, and the first embodimentcould use a single composite chamber and the second embodiment could useseparate chambers.

FIGS. 10 to 12 show a third embodiment. In many respects this resemblesthe second embodiment, and components in the third embodiment, whichcorrespond in general terms to components in the second embodiment aredenoted by the same reference numerals but with the addition of afurther 100.

One difference, which will be observed between the second and thirdembodiments, is that in place of the lid wheel 114 a pair of wheels 314a and 314 b are employed, with the lid sheet being gripped in the nipbetween the wheels 314 a and 314 b, which act as a mangle. These wheelsare knurled or otherwise roughened to improve the grip between thewheels and the lid sheet. The used lid sheet is not wound up but is fedinto a chamber 313, so that no problem arises, as it does in the firsttwo embodiments, with the lid wheel attempting to wind up progressivelylonger lengths of lid as operation of the device continues.

FIG. 11 shows the mouthpiece to be of a somewhat different design tothat shown in FIGS. 4a and 4 b. The mouthpiece is shown as having asingle air inlet 340 in place of the pair of air inlets 140, and thepowder outlet 119 of FIGS. 4a and 4 b bis replaced by a mouthpieceportion 319 of reduced width. It should be understood, however, that thedevice shown in FIGS. 10 to 12 could be modified so as to incorporate amouthpiece more closely resembling FIGS. 4a and 4 b.

FIG. 10 shows the device as being provided with a hinged cover 360, andsuch cover could be provided for either of the first two embodiments.FIG. 12 shows the device as having a window 370 through which indicia onthe strip can be viewed. By printing the strip with numbers or otherindicia, which correlate with the number of pockets from which powderhas been dispensed, or alternatively is to be dispensed, the user isprovided with an indication of how many doses have been used or,alternatively, how many doses remain. Another possibility is to use adose counting device driven by one of the rotating components of theinhalation device. It should be noted that similar indicia and means forviewing those indicia could be provided in all the embodiments.

FIGS. 13 to 16 show a further embodiment of the invention. This issimilar in the principle of its operation to the first embodiment, andcomponents in the fourth embodiment which correspond in general terms tocomponents in the first embodiment are denoted by the same referencenumerals but with the addition of 400.

As in the first embodiment, the device receives a flexible strip, heredenoted as 401, comprising a base sheet 403 in which pockets 402 aredefined and a lid sheet 404. The strip 401, is shown most clearly inFIG. 35. The lid sheet 404 has a loop 404 a formed at the leading endthereof for engagement over a post 471 a extending upwardly from atoothed wheel 471 (described below). The base sheet has a lead portion403 a of reduced width for engagement in a slot 470 a formed in the basewinding wheel 470 (described below). The leading end portions of thebase sheet and lid sheet are not sealed together, as can be seen in FIG.35.

The body 410 comprises a base 410 a and a top 410 b both of generallycircular shape. When the device is assembled the base and top aresnap-fitted together. The body defines a single internal chamber withinwhich the strip 401 is housed and within which are also housed a wheel414 for winding up the used portion of the lid sheet 404, a base windingwheel 470 and an index wheel 416. The index wheel 416 is hollow and anindex ratchet wheel 422 is housed within it. All the wheels justmentioned are mounted in the chamber defined by the body, for rotationalmovement with respect thereto. A pawl 470 b is attached to the body 410and engages the teeth of the base winding wheel 470 to prevent the wheelmoving anticlockwise, thus ensuring that the strip 401 can only proceedforwards through the device.

The lid winding wheel 414 is formed in two parts, namely a toothed wheel471 having teeth 472 and a shaft 473, and a collapsible wheel 474 havinga hollow central shaft 475 and a plurality of resilient arms 476, forexample, as shown, eight such arms, extending from the central shaft 475each at an angle to a radius. The toothed wheel 471 has a lug 477 whichengages in a corresponding notch in the shaft 475 so that the wheels 471and 474 rotate in unison.

The hollow index wheel 416 has external teeth 478 which mesh with theteeth of the base winding wheel 470 and the teeth of the wheel 471.Ratchet teeth 479 are formed on the internal walls of the index wheel416, and the index ratchet wheel 422 has two pawls 480 which engage theratchet teeth 479.

The device further comprises a lever 424 which comprises an arcuate wall481 with a finger tab 482, and an arm 483 which extends inwardly fromthe wall 481 and carries an arcuate array of teeth 484 at its distalend. The lever is pivotally mounted to the center of the base 410 a formovement about an axis which is at the center of the pitch circle of theteeth 484, the teeth 484 mesh with the teeth 485 on the index ratchetwheel 422.

A manifold 486 provides communication between the chamber within thebody 410 and a mouthpiece 420. The manifold has a powder outlet 419 andalso has a passageway 487 to allow used lid strip 404 to pass to thecollapsible wheel 474. optionally, a roller 488 may be provided to guidethe strip 404 into the passageway 487.

A dose monitor ring 489 having teeth 490 is arranged to be rotatablewithin the body base 410 a. On its lower surface this bears indicia (notvisible in the drawings) which can be viewed by the user through awindow 494 in the body 410. It will be noted from FIGS. 16a to 16 d thatthe window can be seen both when the cover 491 (see below) is closed andwhen it is open. The indicia indicate either exactly or approximatelythe number of doses left (or the number of doses used, if preferred).The ring 489 is rotated by virtue of the fact that its teeth 490 areengaged by the teeth 478 of the index wheel.

The device is provided under a cover 491 which is pivotally mounted onthe body 410 by means of a lug 492 on the body top 410 b and acorresponding lug 493 on the body base 410 a. The cover is pivotalbetween an open position (shown in FIG. 14) in which the mouthpiece isexposed and a closed position in which it is not, as is described morefully below.

In operation, the user moves the cover 491 to its open position and thenpresses on the finger tab 482 of the lever 424 to cause it to move asthe lever pivots. This makes the index ratchet wheel 422 rotate which,via the pawls 480, causes the index wheel 416 also to rotate. Rotationof the index wheel 416 produces rotation of both the base winding wheel470 and the lid winding wheel 414, thus peeling the base sheet and lidsheet apart over a distance sufficient to expose a previously unopenedpocket 402 opposite the end of the powder outlet 419 in the manifold486. The patient can then inhale through the mouthpiece, as in thepreceding embodiments.

Successive stages in the operation of the device are shown in FIGS. 16ato 16 d. The device is in its closed position in FIG. 16a. The fingertab 482 of the lever 424 is at this stage in a recess 482 b formed inthe. body 410 (seen more clearly in FIGS. 16b and 16 c). The cover 419is held stationary as the body 410 is rotated anticlockwise, a recess410 c being provided in the periphery of the body to enable the user toinsert a finger for this purpose. The device is thus moved to the partlyopen position shown in FIG. 16b. During this process the lever 424remains stationary with respect to the cover 491. This is achieved bythe lever being provided internally with a resilient arm 424 a the tip424 b of which engages in a recess 491 a in the cover 491. The arm 424 ais attached to the lever 424 via a cylindrical member 424 c. As viewedin FIG. 16a, the arm 424 a extends anticlockwise from the member 424 cover an arc of about 90°. The cylindrical member 424 c is guided in anarcuate slot 410 d formed in the body 410. The slot 410 d extendsthrough an arc of about 180°, and in FIG. 16a the member 424C is shownas being approximately half way along its length. In FIG. 16b it isshown as being at one end.

The user continues to rotate the body 410 from the position shown inFIG. 16b to the position shown in FIG. 16c. During this further rotationtip 424 b of the arm 424 a jumps out of the recess 491 a. This occursbecause, with the member 424 c at one end of the slot 410 d, movement ofthe body 410 carries the member 424 c with it in an anticlockwisedirection and hence compels the arm 424 a likewise to moveanticlockwise. The user then moves the lever 424 by pushing on thefinger tab 482 to cause it to rotate anticlockwise through the positionshown in FIG. 16c to the position shown in FIG. 16d where the finger tab482 re-enters the recess 482 b. The steps thus far described both exposethe mouthpiece 420 and open a fresh blister. The device is therefore nowready for the user to inhale.

After use, the body 410 is rotated clockwise, the lever 424 moving inunison with the body, to bring the device back to the position of FIG.16a.

It will be noted that the collapsible wheel 474 in effect assumes thefunction of the clutch in the first embodiment. As more lid sheet iswound onto the wheel 474 the arms 476 gradually flex inwardly, and theeffect is to keep the external diameter of the reel of wound up lidsheet substantially constant, while the internal diameter thereofgradually decreases.

Instead of the wheel 414 with its collapsible wheel 474 it is possibleto use the alternative structure shown in FIG. 30 or that shown in FIGS.31 and 31a. The principle of operation of the structure shown in FIG. 30is very similar to that of the clutch arrangement shown in FIGS. 25 to29. The structure of FIG. 30 comprises two components 800 and 801. Thecomponent 800 comprises a generally cylindrical hollow housing 802 openat its lower end and three arcuate arrays of teeth 803. The cylinder 802has a slot 804 extending through the upper surface thereof, and a post805 for receiving the leading end of the lid sheet. The component 801comprises a disc 806 provided with three arcuate arrays of teeth 807,and an upright member 808 extending upwardly from the disc 806. Themember 808 is formed of a material, example a plastics material, whichis resilient in torsion.

The two components 800 and 801 are snap-fitted together so that theupper end of the member 808 is received in the slot 804 and cannotrotate with respect thereto. The arrays of teeth 803 and 807 arecoplanar and alternate with one another. The teeth 803 and 807 mesh withthe teeth 478 of the index wheel. Each array 807 is separated from oneof the adjacent arrays 803 (but not from the other) by a gap equal toone tooth. Thus there are three gaps, each of one tooth width, aroundthe assembled arrays. Because the member 808 can flex in torsion, thedisc 806 is free to move back and forth between a position in which thegaps are each on one side of a respective array 807 and a position inwhich the gaps are each on the other side of a respective array 807.This has the effect of producing slippage of the structure shown in FIG.30 with respect to the index wheel.

The structure shown in FIG. 31 is a slipping clutch. It comprises twocomponents 810 and 811, snap-fitted together. The component 810comprises a generally cylindrical housing 812 open at its lower end andhaving a post 813 for receiving the leading end of the lid sheet. Theinterior of the housing 812 is provided with longitudinally extendingserrations 814, as can be seen in FIG. 31a. The component 811 comprisesa cylinder 815 which extends upwardly from a disc 816 provided withteeth 817. The teeth 817 mesh with the teeth 478 of the index wheel. Thecylinder 815 is provided on its outer surface with a pair of pips 818which are in interfering engagement with the serrations 814. When therotational force applied by the component 811 to the component 810 isbelow a predetermined level the components rotate together. However, thecylinder is made of a material, for example a plastics material, whichcan deform radially, and when the rotational force exceeds thepredetermined level such deformation takes place, permitting the pips818 to move over the serrations 814.

Although in the embodiment of FIGS. 13 to 16, with or without themodifications of FIGS. 30 and 31, the base sheet is wound up as well asthe lid sheet, it is not necessary for there also to be a slippingclutch or the like between the index wheel and the base winding wheel.The diameter of the base winding wheel is so chosen that initially thebase sheet is wound up only very loosely, and the tightness with whichthe sheet is wound increases during operation but without ever reachingan unacceptable level. In theory, the base sheet could be wound upprecisely via a slipping clutch or the like, with the lid sheet beingonly loosely wound, but in practice it is much easier to wind up the lidprecisely because it is flat and because it is thinner than the basesheet.

FIGS. 17 to 20 show in diagrammatic form the main operative parts of adevice which has some similarities to those shown in FIGS. 10 to 12,i.e. it is a mangle device. However, it is to be understood that FIGS.17 to 20 do not show a complete device, the chamber for the unused stripand the used base material being omitted. Components in this embodimentwhich correspond in general terms to particular components in theembodiment of FIGS. 10 to 12 are denoted by the same reference numerals,but with the addition of a further 200.

The device of FIGS. 17 to 20 comprises a pair of wheels 514 a and 514 bwhich have meshing teeth formed thereon and which act as a mangleengaging the used lid material. This material is fed into a chamber 513.The wheel 514 b is an idler wheel and is urged into engagement with thewheel 514 a by a compression spring 595 which acts on a carrier 596which carries the wheel 514 b. The wheel 514 a has a ring of gear teeth598 which mesh with teeth 597 formed on an index wheel 516 whichperforms the same indexing function as the index wheel 16 in the firstembodiment and is rotatable in a chamber 515. The chambers are formed ina body 510 and lids 530 a and 530 b are secured to opposite sides of thechamber, inhalation is through a mouthpiece 520. The device is operatedby a lever 524 which turns the index wheel 516 via a pusher arm 526.

The embodiment shown in FIGS. 21 to 24 is another type of mangle device,but one in which both the lid and base sheets pass through the wheels ofthe mangle.

The embodiment of FIGS. 21 to 24 comprises a body 610 defining asubstantially circular chamber 611 and having lids 612 a and 612 bsecured thereto. Within the chamber 611 an index wheel 613 and a baseand lid winding wheel 614 are rotatably mounted, the wheels 613 and 614having gear teeth which mesh with one another. The index wheel 613 hasgrooves 615, and a lid gripper wheel 618, rotatably carried in a carrier619 is also mounted adjacent the grooves 615, downstream of the manifold616. A roller 620 is mounted behind the manifold 616 to guide the lidsheet.

Flexible strip 601 is provided in the chamber 611, the main part of thestrip being initially coiled up around the internal wall of the chamber.The leading end of the strip passes between guide members 622 and 623over part of the circumference of the index wheel 613, with the powdercontaining pockets thereof engaged in the grooves 615. At the pointwhere the strip meets the manifold 616 it is peeled apart, and the lidsheet passes behind the manifold and over the roller 620 while the basesheet passes between the index wheel and the manifold. After themanifold both sheets pass between the index wheel and the lid gripperwheel 618, and are gripped thereby. The front end of the strip is fixedin the base and lid winding wheel 614.

In use, the strip 601 is advanced by rotating the index wheel, by meansof a lever 624, via a pusher arm 6261 which causes correspondingrotation of the base and lid winding wheel. This winds up the base andlid, initially loosely, though increasing in tightness as the operationproceeds, but without, however, the tightness ever reaching anunacceptable level. The lid and base sheets are peeled apart where thestrip meets the manifold 616, presenting a fresh pocket of powder to thepowder outlet 617.

Inhalation is via a mouthpiece 620.

FIGS. 32 to 34 show an embodiment of the invention incorporating, as afurther feature, indicia which instruct the user as to the successivesteps which the user is to take to operate the device. Apart from theindicia, the device is largely the same as the embodiment shown in FIGS.1 to 3, and the same reference numerals are used for the correspondingcomponents. However, there are some additional components, as will beapparent from the following description.

The device shown in FIGS. 32 to 34 has a cover 700 which is pivotallyconnected to the remainder of the device for pivotal movement about anaxis 701. The gear wheels 23 and 25 and the associated components arecovered by a rear wall 702. This extends over the whole of the rear ofthe device, but in the drawings all except a small portion thereof isshown broken away for ease of understanding. The lever 24 is providedwith an arcuate extension 703, on an edge whereof is formed a cam 704.The extension 703 carries indicia in the form of instructions to theuser, in this case the legends “OPEN COVER”, “PRESS BUTTON”, “INHALE”.When the lever 24, and hence the extension 703, are in particularpositions a respective one of these legends is visible through a window705 in the rear wall 702. The distal end of the extension 703constitutes a button 706. The end of the lever 24 remote from theextension 703 carries a tongue 707 pivotal therewith.

FIG. 32 shows the device in its rest position. The legend “OPEN COVER”is visible through the window 705. If a patient now opens the cover 700this brings the device into the position shown in FIG. 33. It will beseen that the top rear edge of the cover has struck the cam 704 andmoved the extension 703 through an angle such as to make the legend“PRESS BUTTON” visible through the window 705. If the user now pressesthe button 706 this causes the lever 24 to rotate, thus opening apowder-containing container, as described in connection with FIGS. 1 to3. This brings the device into the position shown in FIG. 34, in whichthe legend “INHALE” is visible through the window 705. It will also beseen that in the position of FIG. 34 the tongue 707 protrudes upwardly.Accordingly, when the user, having inhaled, closes the cover, the tongue707 is struck by a lug 708 on the underside of the cover, which pushesthe lever 24, with its extension 703, back into the position shown inFIG. 32, once again causing the legend “OPEN COVER” to be displayed.

The device just described not only gives the step-by-step instructionsto the user, thus reducing the risk of a patient being confused, butalso makes it difficult for the patient to use the device other than inthe intended manner, by virtue of the fact that the button 706, oncedepressed, is not again accessible until the user closes the cover andreopens it.

The medicament dispenser of the invention is suitable to dispensingmedicament, particularly for the treatment of respiratory disorders suchas asthma and chronic obstructive pulmonary disease (COPD).

Appropriate medicaments may thus be selected from, for example,analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl ormorphine; anginal preparations, e.g., diltiazem; antiallergics, e.g.,cromoglycate (eg s the sodium salt), ketotifen or nedocromil (eg as thesodium salt); antiinfectives e.g., cephalosporins, penicillins,streptomycin, sulphonamides, tetracyclines and pentamidine;antihistamines, e.g., methapyrilene; anti-inflammatories, e.g.,beclomethasone (eg as the dipropionate ester), fluticasone (eg as thepropionate ester), flunisolide, budesonide, rofleponide, mometasone egas the furoate ester), ciclesonide, triamcinolone (eg as the acetonide)or 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioicacid S-(2-oxo-tetrahydro-furan-3-yl) ester; antitussives, e.g.,noscapine; bronchodilators, e.g., albuterol (eg as free base orsulphate), salmeterol (eg as xinafoate), ephedrine, adrenaline,fenoterol (eg as hydrobromide), formoterol (eg as fumarate),isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine,pirbuterol (eg as acetate), reproterol (eg as hydrochloride), rimiterol,terbutaline (eg as sulphate), isoetharine, tulobuterol or4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]aminolethyl-2(3H)-benzothiazolone;adenosine 2a agonists, eg 2R, 3R, 4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol(e.g. as maleate); α₄ integrin inhibitors eg(2S)-3-[4({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl)amino]propanoic acid (e.g. as free acid or potassium salt), diuretics, e.g.,amiloride; anticholinergics, e.g., ipratropium (eg as bromide),tiotropium, atropine or oxitropium; hormones, e.g. cortisone,hydrocortisone or prednisolone; xanthines, e.g., aminophylline, cholinetheophyllinate, lysine theophyllinate or theophylline; therapeuticproteins and peptides, e.g., insulin or glucagon; vaccines, diagnostics,and gene therapies. It will be clear to a person skilled in the artthat, where appropriate, the medicaments may be used in the form ofsalts, (e.g., as alkali metal or amine salts or as acid addition salts)or as esters (e.g., lower alkyl esters) or as solvates (e.g., hydrates)to optimise the activity and/or stability of the medicament.

Preferred medicaments are selected from albuterol, salmeterol,fluticasone propionate and beclomethasone dipropionate and salts orsolvates thereof, e.g., the sulphate of albuterol and the xinafoate ofsalmeterol.

Medicaments can also be delivered in combinations. Preferredformulations containing combinations of active ingredients containsalbutamol (e.g., as the free base or the sulphate salt) or salmeterol(e.g., as the xinafoate salt) or formoterol (eg as the fumarate salt) incombination with an antiinflammatory steroid such as a beclomethasoneester (e.g., the dipropionate) or a fluticasone ester (e.g., thepropionate) or budesonide. A particularly preferred combination is acombination of fluticasone propionate and salmeterol, or a salt thereof(particularly the xinafoate salt). A further combination of particularinterest is budesoriide and formoterol (e.g. as the fumarate salt).

In the embodiments described above, reference is made to a mouthpiece.However, if the device was to be used for purposes other than oralinhalation some other outlet would be employed, e.g. a nosepiece.

Although preferred embodiments of the invention have been disclosed forillustrative purposes, those skilled in the art will appreciate thatmany additions, modifications and substitutions are possible, withoutdeparting from the scope and spirit of the invention as defined by theaccompanying claims.

What is claimed:
 1. A medicament pack for use in an inhalation device,the pack comprising an elongate strip formed from a base sheet having aplurality of recesses spaced along its length and a lid sheethermetically but peelably sealed thereto to define a plurality ofcontainers, each container having therein inhalable medicament in powderform, the medicament comprising an active ingredient selected from thegroup consisting of albuterol, salmeterol, formoterol, fluticasone,beclomethasone, ciclesonide, mometasone, physiologically acceptablesalts, esters and solvates of all the aforesaid, and budesonide andsolvates thereof.
 2. A medicament pack as claimed in claim 1, whereinthe strip is sufficiently flexible to be wound into a roll.
 3. Amedicament pack as claimed in claim 1, wherein the lid sheet and basesheet have leading end portions which are not sealed to one another. 4.A medicament pack as claimed in claim 3, wherein at least one of thesaid leading end portions is constructed to be attached to a windingmeans.
 5. A medicament pack as claimed in claim 1, wherein the hermeticseal between the base and the lid sheets extends over their whole width.6. A medicament pack according to claim 1, wherein the lid sheet may bepeeled from the base sheet in a longitudinal direction from a first endof the said base sheet.
 7. A medicament pack as claimed in claim 1,wherein said active ingredient is fluticasone propionate.
 8. Amedicament pack as claimed in claim 1, wherein the said activeingredient is salmeterol xinafoate.
 9. A medicament pack as claimed inclaim 1, wherein the medicament pack comprises an active ingredientselected from the group consisting of salbutamol, salmeterol,formoterol, and physiologically acceptable salts, esters or solvates ofall the aforesaid, in combination with an active ingredient selectedfrom the group consisting of beclomethasone, mometasone, ciclesonide,fluticasone, physiologically acceptable salts, esters or solvates of anyof the aforesaid, and budesonide.
 10. A medicament pack as claimed inclaim 9, wherein the medicament comprises fluticasone propionate incombination with an active ingredient selected from the group consistingof salmeterol and physiologically acceptable salts of salmeterol.
 11. Amedicament pack as claimed in claim 10, wherein the medicament comprisesfluticasone propionate and salmeterol xinofoate.
 12. A medicament packas claimed in claim 9, wherein the medicament comprises budesonide incombination with an active ingredient selected from the group consistingof formoterol and physiologically acceptable salts of formoterol.
 13. Amedicament pack as claimed in claim 12, wherein the medicament comprisesbudesonide and formoterol fumarate.
 14. In combination, an inhalationdevice and a medicament pack received therein, said medicament packcomprising an elongated strip formed from a base sheet having aplurality of recesses spaced along its length and a lid sheet peelablysealed in superposed relationship thereto to define a plurality ofcontainers, each having inhalable medicament in powder form, themedicament comprising an active ingredient selected from the groupconsisting of albuterol, salmeterol, formoterol, fluticasone,beclomethasone, ciclesonide, mometasone physiologically accepted salts,esters and solvates of all the aforesaid, budesonide and solvatesthereof; and said inhalation device comprising: an opening stationreceiving a container of said medicament pack; a peeler positioned toengage peelable sheets of a container which has been received in saidopening station so as to peel apart the peelable sheets, opening thecontainer; and an outlet positioned in communication with an openedcontainer through which a user inhale the medicament in powder form fromthe opened container.
 15. The combination of claim 14, wherein saidactive ingredient is fluticasone propionate.
 16. The combination ofclaim 14, wherein said active ingredient is salmeterol xinafoate. 17.The combination of claim 14, wherein the medicament comprises an activeingredient selected from the group consisting of salbutamol, salmeterol,formoterol, and physiologically acceptable salts, esters or solvates ofall the aforesaid, in combination with an active ingredient selectedfrom the group consisting of beclomethasone, fluticasone, ciclesonide,mometasone, physiologically acceptable salts, esters or solvates of anyof the aforesaid, and budesonide.
 18. The combination of claim 17,wherein the medicament comprises fluticasone propionate in combinationwith an active ingredient selected from the group consisting ofsalmeterol and physiologically acceptable salts of salmeterol.
 19. Thecombination of claim 18, wherein the medicament comprises fluticasonepropionate and salmeterol xinofoate.
 20. The combination of claim 17,wherein the medicament comprises budesonide in combination with anactive ingredient selected from the group consisting of formoterol andphysiologically acceptable salts of formoterol.
 21. The combination ofclaim 20, wherein the medicament comprises budesonide and formoterolfumarate.
 22. The combination of claim 18, wherein the medicamentcomprises budesonide in combination with an active ingredient selectedfrom the group consisting of formoterol and physiologically acceptablesalts of formoterol.
 23. The combination of claim 22, wherein themedicament comprises budesonide and formoterol fumarate.